Cerebral Atherosclerotic StenosisNCT06683118

Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis

A study testing Rapamycin neurovascular Balloon Catheter and Conventional Balloon in people with Cerebral Atherosclerotic Stenosis, run by MicroPort NeuroTech Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cerebral Atherosclerotic Stenosis
What is being tested?: Rapamycin neurovascular Balloon Catheter and Conventional Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 212 participants
Where: 2 sitesChina
Study dates: 27 May 2024to 27 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

History of acute ischemic stroke within 2 weeks;
Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
Target vessels complete occlusion or with thrombus in target vessels;
Target vessel with severe calcification or distortion that making interventional device is difficult to place;
History of stenting in the target artery;
Target vessel restenosis following stenting or balloon angioplasty;

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Combined with other lesion with ≥70% stenosis in target vessel.
Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
History of intracranial hemorrhage within 90days.
Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
Allergic to contrast agents or rapamycin;
Pregnant or lactating women;
Participating or intending to participate in any other drug/device clinical trials;
Life expectancy <1 year;
Any other conditions that the investigator deems the patient unsuitable for enrollment.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Tiantan Hospital Affiliated of Peking University
Beijing, Beijing Municipality
Huashan Hospital Affiliated of Fudan University
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis

Conditions: Cerebral Atherosclerotic Stenosis
Being tested: Rapamycin neurovascular Balloon Catheter, Conventional Balloon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rapamycin neurovascular Balloon CatheterDevice
Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
Conventional BalloonDevice
Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

Study groups in NCT06683118
Study group	Role	What they receive
experimental group	Experimental	Not described Receives: Device: Rapamycin neurovascular Balloon Catheter
control group	Active comparator	Not described Receives: Device: Conventional Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

Target lesion restenosis rate at 6 month postoperative
The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.
Measured: 180±30days

Secondary outcomes (7)

Technical succeed rate
defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction
Measured: Intraoperation
Target vascular-related stroke or death at 30 days postoperatively
Measured: 30±7days
Any stroke or death at 30 days postoperatively
Measured: 30±7days
Target vascular-related stroke or death at 6 month postoperatively
Measured: 180±30days
Any stroke or death at 6 month postoperatively
Measured: 180±30days
Target vascular-related stroke or death at 12 month postoperatively
Measured: 360±60days
Any stroke or death at 12 month postoperatively
Measured: 360±60days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 202427 Jul 2026

First posted12 Nov 2024
Study start27 May 2024
Primary completion27 Jul 2025 (estimated)
Study completion27 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral Atherosclerotic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 212 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06683118
Sponsor's protocol ID: JUJI-2023-01-CIP-00
Status last verified: Aug 2024
First submitted: 8 Nov 2024
Last updated: 12 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Pemafibrate for Symptomatic ICAS RCT
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EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
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Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
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Determination of the Best Therapeutic Strategy, Interventional With Best Medical Management (BMM) Versus BMM Alone, for Patients With Symptomatic Moderate <70% Atherosclerotic Carotid Artery Stenosis: the SIMCA Multicenter Randomized Trial
Carotid Stenosis

All Cerebral Atherosclerotic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS
ClinicalTrials.gov ID: NCT06683118
Acronym / sponsor ID: JUJI-2023-01-CIP-00
Conditions: Cerebral Atherosclerotic Stenosis
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 212 participants (estimated)
Lead sponsor: MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 May 2024 (actual)
Primary completion: 27 Jul 2025 (estimated)
Study completion: 27 Jul 2026 (estimated)
First posted: 12 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Device: Rapamycin neurovascular Balloon Catheter
control group	Active comparator	Device: Conventional Balloon

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (17 listed)

History of acute ischemic stroke within 2 weeks;
Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
Target vessels complete occlusion or with thrombus in target vessels;
Target vessel with severe calcification or distortion that making interventional device is difficult to place;
History of stenting in the target artery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rapamycin neurovascular Balloon CatheterDrug-coated balloon for the symptomatic cerebral atherosclerotic stenosis	Device	experimental group
Conventional BalloonConventional Balloon for the symptomatic cerebral atherosclerotic stenosis	Device	control group

Primary outcome

Target lesion restenosis rate at 6 month postoperative
Time frame: 180±30days
The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.

7 secondary outcomes

Technical succeed rate
Time frame: Intraoperation
Target vascular-related stroke or death at 30 days postoperatively
Time frame: 30±7days
Any stroke or death at 30 days postoperatively
Time frame: 30±7days
Target vascular-related stroke or death at 6 month postoperatively
Time frame: 180±30days
Any stroke or death at 6 month postoperatively
Time frame: 180±30days
Target vascular-related stroke or death at 12 month postoperatively
Time frame: 360±60days
Any stroke or death at 12 month postoperatively
Time frame: 360±60days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.

Related trials for Cerebral Atherosclerotic Stenosis

Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
Not yet recruiting
Determination of the Best Therapeutic Strategy, Interventional With Best Medical Management (BMM) Versus BMM Alone, for Patients With Symptomatic Moderate <70% Atherosclerotic Carotid Artery Stenosis: the SIMCA Multicenter Randomized Trial
Carotid Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rapamycin neurovascular Balloon Catheter and Conventional Balloon in people with Cerebral Atherosclerotic Stenosis, run by MicroPort NeuroTech Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion restenosis rate at 6 month postoperative (time frame: 180±30days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06683118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.